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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameantimicrobial susceptibility system
Regulation Number866.1645
ApplicantBD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
PMA NumberP800030
Supplement NumberS002
Date Received10/13/1982
Decision Date03/01/1983
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
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